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NCT06220097Active, not recruitingPhase 2

Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies

Study on the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen in CD19-targeting CAR-T Therapies

Source: ClinicalTrials.gov · Last updated 17 Jul 2025

Brief summary (registry, in English)

The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therapies of CD19 CAR-T cells. The main question it aims to answer is: • the efficacy of the mitoxantrone hydrochloride liposome injection-containing combination regimens in bridging therapies of CD19 CAR-T cells. Participants will receive combination bridging regimens including mitoxantrone hydrochloride liposomal injection and CAR-T cell therapy to see if the combination regimens have a positive effect on the efficacy of bridging therapies.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
28 (estimated)
First submitted
11 Jan 2024
Start date
1 Feb 2022
Primary completion date
1 Aug 2024
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT number
NCT06220097

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 28
  • From 1 Feb 2022 to the primary completion date, 1 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with doxorubicin or other anthracyclines with a total cumulative dose of doxorubicin \>360 mg/m2 (other anthracyclines convert 1 mg of doxorubicin to 2 mg epirubicin).
  • Concomitant other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, poorly controlled pulmonary diseases, or psychiatric disorders.
  • Investigators judge patients with central nervous system involvement who may be at high risk of receiving bridging therapy and CD19 CAR-T cell treatment.
  • Patients with relapse after allogeneic hematopoietic stem cell transplantation who have had grade 3\~4 acute graft-versus-host response (GVHD).

Other illness

  • Hypersensitivity to any of the study drugs or their components.
  • Participants with other active malignancies within five years.
  • Active autoimmune disease requiring systemic immunosuppressive therapy.
  • Other conditions considered to increase the risk to the subject or interfere with the results of the trial by the researcher.

Other

  • Patients who are pregnant or breast-feeding.

Who the study is looking for

  • Aged ≥ 18 years and \<75 years.
  • Eastern Cooperative Oncology Group score≤ 2.
  • Clinically diagnosed refractory or relapsed B-cell malignancies. Relapse refers to "relapse after a complete response (CR) from initial chemotherapy"; refractory refers to "diagnosis can be made if any of the following are met:(1) tumor shrinkage of \<50% or disease progression (PD) after standard chemotherapy; (2) CR is achieved by standard chemotherapy but relapses within six months, (3) 2 or more recurrences after CR, (4) recurrence after hematopoietic stem cell transplantation"; B-cell malignancies include the following 3 categories: (1) B-cell acute lymphoblastic leukemia (B-ALL); (2) indolent B-cell lymphoma (CLL, FL, MZL); (3) aggressive B-cell lymphoma (DLBCL, BL, MCL).
  • Flow cytometry (FCM) or immunohistochemistry showed positive CD19 expression in tumor cells;
  • Organ function needs to meet the following conditions:
    • 1\) EF \>50%, and there is no obvious abnormality on ECG; 2) SpO2≥90%; 3) Cr≤2.5 ULN; 4) ALT and AST≤5 ULN, TBil≤3 ULN; 6. Negativity of blood pregnancy test for women, and participants use effective methods of contraception until the last follow-up. 7. The patient or his or her legal guardian voluntarily participates in and signs an informed consent form.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Union Hospital, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.